McCallum RW et al. (2007) Efficacy of mitemcinal, a motilin agonist, on gastrointestinal symptoms in patients with symptoms suggesting diabetic gastropathy: a randomized, multi-center, placebo-controlled trial. Aliment Pharmacol Ther 26: 107–116

Current research into effective treatments for gastroparesis is focused on agonists of motilin, a peptide hormone that accelerates gastric emptying. McCallum and colleagues studied whether mitemcinal, an orally administered motilin agonist, is effective at improving diabetes-related gastroparesis symptoms.

This randomized, double-blind, placebo-controlled study included 392 insulin-requiring patients (mean age 48.7 years, 64.5% female) with either type 1 or type 2 diabetes and >3 months' history of gastroparesis symptoms. Patients were randomly allocated to receive 5 mg mitemcinal twice-daily (n = 131), 10 mg mitemcinal twice-daily (n = 130) or placebo (n = 131) for 12 weeks, followed by 4 weeks of placebo for all patients. Patients reported symptom information and adverse events every week, and attended monthly assessment visits.

Patients rated their weekly response to treatment as either positive or negative. 'Overall responders' required positive responses for ≥75% of trial weeks, and 'complete responders' required three consecutive months with ≥50% of weekly responses being positive. There were significantly more overall responders in the 10 mg mitemcinal group than in the placebo group (P <0.05). In a subgroup analysis, which included patients with BMI <35 kg/m2 and hemoglobin A1c <10%, there were significantly more overall responders (P = 0.0002) and complete responders (P = 0.003) in the 10 mg mitemcinal group than in the placebo group. Overall, the frequency of adverse events did not differ between groups.

The authors conclude that mitemcinal shows promise in a subset of diabetic patients with gastroparesis who should be targeted in further studies of this agent.